search
Back to results

Cardioprotective Effect of Acute Exercise in Breast Cancer Patients (CardioProtEx)

Primary Purpose

Early-stage Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Acute Exercise
Sponsored by
Technical University of Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-stage Breast Cancer focused on measuring Breast Cancer, Exercise, Doxorubicin, anthracyclines, Cardiotoxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Woman with non-metastatic breast cancer not previously treated.
  • Scheduled to receive neoadjuvant doxorubicin chemotherapy.
  • Receive the oncologist´s approval for the practice of exercise.
  • Acceptance of randomization.
  • To sign an informed consent form before starting any measurement or procedure related to the project.

Exclusion Criteria:

  • Patients who receive initial surgery and who are not going to receive neoadjuvant treatment.
  • Contraindications to perform stress tests following the recommendations of the American Thoracic Society.
  • Pre-existing cardiovascular disease.
  • Body mass index (BMI) > 35 kg/m2.
  • Diabetes mellitus.
  • Renal disease.
  • Severe anemia.
  • Pregnacy.
  • Current smoking status.

Sites / Locations

  • "Ramón y Cajal" HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Patients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines) 24-48 hours prior to each cycle of anthracyclines.

Patients will receive standard treatment for each type of tumor proposed by the hospital. This group of patients will be provided with the international recommendations on physical exercise for cancer patients.

Outcomes

Primary Outcome Measures

NT-proBNP
Biomarker of cardiac injury value in blood tests

Secondary Outcome Measures

Cardiac Troponin I
Biomarker of cardiac injury value in blood tests
Blood Pressure
Resting blood pressure assesed by sphyngomanometer
Left Ventricular Ejection Fraction (LVEF)
Change in left ventricular systolic function quantified by transthoracic echocardiography

Full Information

First Posted
July 13, 2022
Last Updated
April 26, 2023
Sponsor
Technical University of Madrid
search

1. Study Identification

Unique Protocol Identification Number
NCT05467111
Brief Title
Cardioprotective Effect of Acute Exercise in Breast Cancer Patients
Acronym
CardioProtEx
Official Title
Cardioprotective Effect of Acute Exercise in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage (NT-proBNP). Given the fact NT-proBNP attenuation has been observed with one session performed 24h before the first treatment, we propose to verify these findings in each cycle of doxorubicin analyzing how each type of exercise (aerobic, strength or combined aerobic + strength) may impact on anthracycline-induced cardiotoxicity, since this observation may be relevant considering the feasibility and low cost this implementation would represent in clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-stage Breast Cancer
Keywords
Breast Cancer, Exercise, Doxorubicin, anthracyclines, Cardiotoxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Patients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines) 24-48 hours prior to each cycle of anthracyclines.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will receive standard treatment for each type of tumor proposed by the hospital. This group of patients will be provided with the international recommendations on physical exercise for cancer patients.
Intervention Type
Other
Intervention Name(s)
Acute Exercise
Intervention Description
Patients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines, as aerobic exercise, strength training or combined training) 24-48 hours prior to each cycle of anthracyclines.
Primary Outcome Measure Information:
Title
NT-proBNP
Description
Biomarker of cardiac injury value in blood tests
Time Frame
24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Secondary Outcome Measure Information:
Title
Cardiac Troponin I
Description
Biomarker of cardiac injury value in blood tests
Time Frame
24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Title
Blood Pressure
Description
Resting blood pressure assesed by sphyngomanometer
Time Frame
24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Change in left ventricular systolic function quantified by transthoracic echocardiography
Time Frame
0-14 days prior to the first treatment ( according to the usual clinical practice) and in the follow-up period (6 months after completion of the anthracycline treatment).
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
Assesed using the validated EORTC-QLQ-C30 quality of life questionnaire
Time Frame
Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
Title
Fatigue
Description
Assesed using the validated Functional Assessment of Cancer Therapy: Fatigue (FACT-F)
Time Frame
Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
Title
Physical Activity
Description
Assesed using the validated International Physical Activity Questionnaire (IPAQ-SF)
Time Frame
Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
Title
Assessment of functional mobility
Description
Assesed using the Timed Up and Go (TUG) test
Time Frame
0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
Title
Assessment of lower extremity strength and power
Description
Assesed using the Sit to Stand test
Time Frame
0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
Title
Assessment of isometric handgrip
Description
Assesed using the hand grip dynamometer test
Time Frame
0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Woman with non-metastatic breast cancer not previously treated. Scheduled to receive neoadjuvant doxorubicin chemotherapy. Receive the oncologist´s approval for the practice of exercise. Acceptance of randomization. To sign an informed consent form before starting any measurement or procedure related to the project. Exclusion Criteria: Patients who receive initial surgery and who are not going to receive neoadjuvant treatment. Contraindications to perform stress tests following the recommendations of the American Thoracic Society. Pre-existing cardiovascular disease. Body mass index (BMI) > 35 kg/m2. Diabetes mellitus. Renal disease. Severe anemia. Pregnacy. Current smoking status.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Alonso
Phone
+ 34 678942096
Email
maria.alonsod@alumnos.upm.es
Facility Information:
Facility Name
"Ramón y Cajal" Hospital
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Alonso
Phone
+34 678942096
Email
maria.alonsod@alumnos.upm.es
First Name & Middle Initial & Last Name & Degree
María Fernández Abad

12. IPD Sharing Statement

Learn more about this trial

Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

We'll reach out to this number within 24 hrs